Using hymecromone to treat primary sclerosing cholangitis in adolescents and adults
Official title: A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).
Run by Stanford University · NCT05295680 · Data updated 2026-11-12
This study is testing if adding hymecromone to standard treatment can help adolescents and adults with primary sclerosing cholangitis feel better and improve their liver function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 14 Years to 75 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 2 sites (Redwood City, California and 1 other locations) |
| Status | Recruiting |
| Started | May 10, 2023 |
| Main results expected | May 2027 |
| Study ends | December 2027 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT05295680 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents and adults diagnosed with primary sclerosing cholangitis confirmed by liver biopsy or imaging.
✕Probably not a fit
Patients currently receiving biologic therapies or with serious liver disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of hymecromone combined with standard care for treating adolescents and adults diagnosed with primary sclerosing cholangitis (PSC). The primary objective is to compare the efficacy of this combination therapy against standard care alone. Secondary objectives include assessing changes in alkaline phosphatase levels and various biomarkers related to PSC over a six-month treatment period. Participants will be monitored for improvements in liver function and disease markers.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing primary sclerosing cholangitis, potentially improving patient outcomes.
How similar studies have gone: While there is limited data on hymecromone for PSC, similar studies exploring novel treatments for liver diseases have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging study * If history of endoscopically confirmed inflammatory bowel disease, currently stable based on Mayo Score / Disease Activity Index (DAI) for Ulcerative Colitis Score ≤ 1, normal inflammatory markers (ESR, CRP and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months Exclusion Criteria: * Currently receiving biologic therapies * Known allergy to hymecromone * Cholangiocarcinoma * Pregnancy * Serious liver disease
Where it's running
-
Stanford Clinic
Redwood City, California, United States Recruiting -
Stanford Clinic
Stanford, California, United States Recruiting
Study contacts
- Principal investigator: Aparna Goel, MD — Stanford University
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Elafibranor for adults with primary sclerosing cholangitis
This trial will see if taking elafibranor once daily helps adults with primary sclerosing cholangitis compared with a placebo.
-
TAK-781 treatment in healthy adults and people with non-cirrhotic primary sclerosing cholangitis
This study will test whether TAK-781 is safe and tolerable in healthy adults and in people with non-cirrhotic primary sclerosing cholangitis while measuring how the body handles and responds to the drug.
-
Preventing recurrence of primary sclerosing cholangitis after liver transplantation
This study is testing if a daily medication called fenofibrate can help prevent primary sclerosing cholangitis from coming back in people who have had a liver transplant.
-
LEOPARD: Predicting liver transplant dropout with AI in European patients
This project tests new AI-based models to predict which liver transplant candidates are at highest risk of dropout or death while on the waitlist.
-
Collecting data to improve liver transplantation predictions
This study is trying to use AI to better predict which liver transplant candidates are at risk of dropping out of the waitlist, so that more people can get fair access to transplants across Europe.
-
Identifying liver disease-specific gut microbiomes
This study is trying to find out if certain gut bacteria are linked to chronic liver diseases in adults, including autoimmune hepatitis and primary biliary cholangitis, by analyzing blood and stool samples from patients and their household members.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.